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JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
Efficacy of a metered-dose 8% lidocaine pump spray for patients with post-herpetic neuralgia.
Pain Medicine 2009
OBJECTIVE: Topical lidocaine patch is effective in the treatment of post-herpetic neuralgia (PHN), but not suited for paroxysmal pain because of the long latency of analgesia. Here, we examined the efficacy of 8% lidocaine pump spray (Xylocaine pump spray, XPS) for PHN.
DESIGN: Twenty-four patients with PHN were recruited into a randomized, double-blind, placebo-controlled, crossover study (study 1), and 100 patients with PHN were recruited into an open-labeled study (study 2). In study 1, patients were randomized to receive either XPS or saline placebo pump spray (PPS) applied to the painful skin areas. Following a 7-day period, patients were crossed over to receive the alternative treatment. In study 2, XPS was prescribed for patients who were advised to use the spray anytime, with a 2-hour gap between applications, for 2 weeks. The pain was assessed with a visual analogue scale (VAS). Details of use were noted in the diary.
RESULTS: In study 1, greater decreases in VAS of persistent pain followed application of XPS (baseline: 6.1 +/- 1.7 cm, 15-minute post-spray: 2.3 +/- 2.5 cm, mean +/- SD) than with PPS (6.1 +/- 1.7 cm, 5.7 +/- 1.6 cm, [P < 0.01]). The effect persisted for a median of 4.5 hours (range, 2 to 24 hours) after application. In study 2, 13 of 100 patients discontinued the treatment because of mild local side effects or insufficient effect. In the remaining 87 patients, XPS maintained significant pain relief relative to baseline throughout the 2-week period. Satisfaction with the therapy was reported by 79% of patients.
CONCLUSIONS: In both studies, XPS provided a significant improvement in PHN due to its prompt analgesia, lack of systemic side effects, and convenience of use.
DESIGN: Twenty-four patients with PHN were recruited into a randomized, double-blind, placebo-controlled, crossover study (study 1), and 100 patients with PHN were recruited into an open-labeled study (study 2). In study 1, patients were randomized to receive either XPS or saline placebo pump spray (PPS) applied to the painful skin areas. Following a 7-day period, patients were crossed over to receive the alternative treatment. In study 2, XPS was prescribed for patients who were advised to use the spray anytime, with a 2-hour gap between applications, for 2 weeks. The pain was assessed with a visual analogue scale (VAS). Details of use were noted in the diary.
RESULTS: In study 1, greater decreases in VAS of persistent pain followed application of XPS (baseline: 6.1 +/- 1.7 cm, 15-minute post-spray: 2.3 +/- 2.5 cm, mean +/- SD) than with PPS (6.1 +/- 1.7 cm, 5.7 +/- 1.6 cm, [P < 0.01]). The effect persisted for a median of 4.5 hours (range, 2 to 24 hours) after application. In study 2, 13 of 100 patients discontinued the treatment because of mild local side effects or insufficient effect. In the remaining 87 patients, XPS maintained significant pain relief relative to baseline throughout the 2-week period. Satisfaction with the therapy was reported by 79% of patients.
CONCLUSIONS: In both studies, XPS provided a significant improvement in PHN due to its prompt analgesia, lack of systemic side effects, and convenience of use.
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